Delivery systems for delivering prosthetic heart valve devices and associated methods

ABSTRACT

Systems for delivering prosthetic heart valve devices can include, for example, an elongated catheter body, a deliver capsule carried by the catheter body, and an expandable atraumatic member. The delivery capsule includes a platform and a housing having an outer wall and a proximal rim, and the platform is configured to be releasably coupled to a prosthetic heart valve device. The housing is configured to slide along the platform from a containment configuration to a deployment configuration. The expandable atraumatic member has an atraumatic surface and a peripheral portion. The atraumatic member has a compacted configuration and an expanded configuration in which the peripheral portion extends laterally outward over the proximal rim of the housing to protect tissue of the heart and the vasculature from potentially being damaged by the proximal rim of the housing as the delivery system is withdrawn in a proximal direction through the patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application incorporates by reference the subject matter ofthe following applications in their entireties: (1) International PatentApplication No. PCT/US2014/029549, filed Mar. 14, 2014; (2)International Patent Application No. PCT/US2012/061219, filed Oct. 19,2012; (3) International Patent Application No. PCT/US2012/061215, filedOct. 19, 2012; (4) International Patent Application No.PCT/US2012/043636, filed Jun. 21, 2012; (5) U.S. application Ser. No.15/490,047, filed Apr. 18, 2017; (6) U.S. application Ser. No.15/490,008, filed Apr. 18, 2017; and (7) U.S. application Ser. No.15/490,024, filed Apr. 18, 2017.

TECHNICAL FIELD

The present technology relates generally to systems for deliveringprosthetic heart valve devices. In particular, several embodiments ofthe present technology are related to hydraulic systems forpercutaneously delivering prosthetic heart valve devices into mitralvalves and associated methods.

BACKGROUND

Heart valves can be affected by several conditions. For example, mitralvalves can be affected by mitral valve regurgitation, mitral valveprolapse and mitral valve stenosis. Mitral valve regurgitation isabnormal leaking of blood from the left ventricle into the left atriumcaused by a disorder of the heart in which the leaflets of the mitralvalve fail to coapt into apposition at peak contraction pressures. Themitral valve leaflets may not coapt sufficiently because heart diseasesoften cause dilation of the heart muscle, which in turn enlarges thenative mitral valve annulus to the extent that the leaflets do not coaptduring systole. Abnormal backflow can also occur when the papillarymuscles are functionally compromised due to ischemia or otherconditions. More specifically, as the left ventricle contracts duringsystole, the affected papillary muscles do not contract sufficiently toeffect proper closure of the leaflets.

Mitral valve prolapse is a condition when the mitral leaflets bulgeabnormally up in to the left atrium. This can cause irregular behaviorof the mitral valve and lead to mitral valve regurgitation. The leafletsmay prolapse and fail to coapt because the tendons connecting thepapillary muscles to the inferior side of the mitral valve leaflets(chordae tendineae) may tear or stretch. Mitral valve stenosis is anarrowing of the mitral valve orifice that impedes filling of the leftventricle in diastole.

Mitral valve regurgitation is often treated using diuretics and/orvasodilators to reduce the amount of blood flowing back into the leftatrium. Surgical approaches (open and intravascular) for either therepair or replacement of the valve have also been used to treat mitralvalve regurgitation. For example, typical repair techniques involvecinching or resecting portions of the dilated annulus. Cinching, forexample, includes implanting annular or peri-annular rings that aregenerally secured to the annulus or surrounding tissue. Other repairprocedures suture or clip the valve leaflets into partial appositionwith one another.

Alternatively, more invasive procedures replace the entire valve itselfby implanting mechanical valves or biological tissue into the heart inplace of the native mitral valve. These invasive proceduresconventionally require large open thoracotomies and are thus verypainful, have significant morbidity, and require long recovery periods.Moreover, with many repair and replacement procedures, the durability ofthe devices or improper sizing of annuloplasty rings or replacementvalves may cause additional problems for the patient. Repair proceduresalso require a highly skilled cardiac surgeon because poorly orinaccurately placed sutures may affect the success of procedures.

Less invasive approaches to aortic valve replacement have beenimplemented in recent years. Examples of pre-assembled, percutaneousprosthetic valves include, e.g., the CoreValve Revalving® System fromMedtronic/Corevalve Inc. (Irvine, Calif., USA) and the EdwardsSapien®Valve from Edwards Lifesciences (Irvine, Calif., USA). Both valvesystems include an expandable frame and a tri-leaflet bioprostheticvalve attached to the expandable frame. The aortic valve issubstantially symmetric, circular, and has a muscular annulus. Theexpandable frames in aortic applications have a symmetric, circularshape at the aortic valve annulus to match the native anatomy, but alsobecause tri-leaflet prosthetic valves require circular symmetry forproper coaptation of the prosthetic leaflets. Thus, aortic valve anatomylends itself to an expandable frame housing a replacement valve sincethe aortic valve anatomy is substantially uniform, symmetric, and fairlymuscular. Other heart valve anatomies, however, are not uniform,symmetric or sufficiently muscular, and thus transvascular aortic valvereplacement devises may not be well suited for other types of heartvalves.

BRIEF DESCRIPTION OF THE DRAWINGS

Many aspects of the present disclosure can be better understood withreference to the following drawings. The components in the drawings arenot necessarily to scale. Instead, emphasis is placed on illustratingclearly the principles of the present disclosure. Furthermore,components can be shown as transparent in certain views for clarity ofillustration only and not to indicate that the illustrated component isnecessarily transparent. The headings provided herein are forconvenience only.

FIG. 1 is a schematic, cross-sectional illustration of the heart showingan antegrade approach to the native mitral valve from the venousvasculature in accordance with various embodiments of the presenttechnology.

FIG. 2 is a schematic, cross-sectional illustration of the heart showingaccess through the inter-atrial septum (IAS) maintained by the placementof a guide catheter over a guidewire in accordance with variousembodiments of the present technology.

FIGS. 3 and 4 are schematic, cross-sectional illustrations of the heartshowing retrograde approaches to the native mitral valve through theaortic valve and arterial vasculature in accordance with variousembodiments of the present technology.

FIG. 5 is a schematic, cross-sectional illustration of the heart showingan approach to the native mitral valve using a trans-apical puncture inaccordance with various embodiments of the present technology.

FIG. 6 is an isometric view of a system for delivering a prostheticheart valve device configured in accordance with some embodiments of thepresent technology.

FIG. 7A is a partially schematic cross-sectional view of a distalportion of a system in a containment configuration in accordance withsome embodiments of the present technology.

FIG. 7B is a partially schematic cross-sectional view of a distalportion of a system in a deployment configuration in accordance withsome embodiments of the present technology.

FIG. 8A is a side view of an atraumatic member for use in a deliverysystem in accordance with some embodiments of the present technology.

FIG. 8B is a side cross-sectional view of an atraumatic member for usein a delivery system in accordance with some embodiments of the presenttechnology.

FIGS. 9A and 9B are side views of the atraumatic member of FIG. 8A whenthe capsule is in the fully extended position (FIG. 9A) and the fullyretracted position (FIG. 9B).

FIGS. 10A and 10B are side views of atraumatic members for use indelivery systems in accordance with some embodiments of the presenttechnology, and FIG. 10C is a top view of the atraumatic member of FIG.10B.

FIG. 11 is a side view of the atraumatic members of FIGS. 10A and 10Bafter the atraumatic member has expanded.

FIG. 12A is a cross-sectional side view and FIG. 12B is a top viewschematically illustrating a prosthetic heart valve device in accordancewith some embodiments of the present technology.

FIGS. 13A and 13B are cross-sectional side views schematicallyillustrating aspects of delivering a prosthetic heart valve device inaccordance with some embodiments of the present technology.

FIG. 14 is a top isometric view of a prosthetic heart valve device inaccordance with some embodiments of the present technology.

FIG. 15 is a side view and FIG. 16 is a bottom isometric view of theprosthetic heart valve device of FIG. 14.

FIG. 17 is a side view and FIG. 18 is a bottom isometric view of aprosthetic heart valve device in accordance with some embodiments of thepresent technology.

FIG. 19 is a side view and FIG. 20 is a bottom isometric view of theprosthetic heart valve device of FIGS. 17 and 18 at a partially deployedstate with respect to a delivery device.

FIG. 21 is an isometric view of a valve support for use with prostheticheart valve devices in accordance with the present technology.

FIGS. 22 and 23 are side and bottom isometric views, respectively, of aprosthetic heart valve attached to the valve support of FIG. 21.

FIGS. 24 and 25 are side views schematically showing valve supports inaccordance with additional embodiments of the present technology.

DETAILED DESCRIPTION

The present technology is generally directed to hydraulic systems fordelivering prosthetic heart valve devices and associated methods.Specific details of several embodiments of the present technology aredescribed herein with reference to FIGS. 1-25. Although many of theembodiments are described with respect to devices, systems, and methodsfor delivering prosthetic heart valve devices to a native mitral valve,other applications and other embodiments in addition to those describedherein are within the scope of the present technology. For example, atleast some embodiments of the present technology may be useful fordelivering prosthetics to other valves, such as the tricuspid valve orthe aortic valve. It should be noted that other embodiments in additionto those disclosed herein are within the scope of the presenttechnology. Further, embodiments of the present technology can havedifferent configurations, components, and/or procedures than those shownor described herein. Moreover, a person of ordinary skill in the artwill understand that embodiments of the present technology can haveconfigurations, components, and/or procedures in addition to those shownor described herein, and that these and many embodiments can be withoutseveral of the configurations, components, and/or procedures shown ordescribed herein without deviating from the present technology.

With regard to the terms “distal” and “proximal” within thisdescription, unless otherwise specified, the terms can referencerelative positions of portions of a prosthetic valve device and/or anassociated delivery device with reference to an operator and/or alocation in the vasculature or heart. For example, in referring to adelivery catheter suitable to deliver and position various prostheticvalve devices described herein, “proximal” can refer to a positioncloser to the operator of the device or an incision into thevasculature, and “distal” can refer to a position that is more distantfrom the operator of the device or further from the incision along thevasculature (e.g., the end of the catheter). With respect to aprosthetic heart valve device, the terms “proximal” and “distal” canrefer to the location of portions of the device with respect to thedirection of blood flow. For example, proximal can refer to an upstreamposition or a location where blood flows into the device (e.g., inflowregion), and distal can refer to a downstream position or a locationwhere blood flows out of the device (e.g., outflow region).

Overview

Several embodiments of the present technology are directed to deliverysystems and mitral valve replacement devices that address the uniquechallenges of percutaneously replacing native mitral valves. Thedelivery systems and implantable devices are well-suited to berecaptured in a percutaneous delivery device after being partiallydeployed for repositioning or removing the device. The delivery systemsare also well-suited for deploying self-expanding prosthetic heart valvereplacement devices and withdrawing the delivery systems from thepatient. Compared to replacing aortic valves, percutaneous mitral valvereplacement faces unique anatomical obstacles that render percutaneousmitral valve replacement significantly more challenging than aorticvalve replacement. First, unlike relatively symmetric and uniform aorticvalves, the mitral valve annulus has a non-circular D-shape orkidney-like shape, with a non-planar, saddle-like geometry often lackingsymmetry. The complex and highly variable anatomy of mitral valves makesit difficult to design a mitral valve prosthesis that conforms well tothe native mitral annulus of specific patients. As a result, theprosthesis may not fit well with the native leaflets and/or annulus,which can leave gaps that allows backflow of blood to occur. Forexample, placement of a cylindrical valve prosthesis in a native mitralvalve may leave gaps in commissural regions of the native valve throughwhich perivalvular leaks may occur.

Current prosthetic valves developed for percutaneous aortic valvereplacement are unsuitable for use in mitral valves. First, many ofthese devices require a direct, structural connection between thestent-like structure that contacts the annulus and/or leaflets and theprosthetic valve. In several devices, the stent posts which support theprosthetic valve also contact the annulus or other surrounding tissue.These types of devices directly transfer the forces exerted by thetissue and blood as the heart contracts to the valve support and theprosthetic leaflets, which in turn distorts the valve support from itsdesired cylindrical shape. This is a concern because most cardiacreplacement devices use tri-leaflet valves, which require asubstantially symmetric, cylindrical support around the prosthetic valvefor proper opening and closing of the three leaflets over years of life.As a result, when these devices are subject to movement and forces fromthe annulus and other surrounding tissues, the prostheses may becompressed and/or distorted causing the prosthetic leaflets tomalfunction. Moreover, a diseased mitral annulus is much larger than anyavailable prosthetic aortic valve. As the size of the valve increases,the forces on the valve leaflets increase dramatically, so simplyincreasing the size of an aortic prosthesis to the size of a dilatedmitral valve annulus would require dramatically thicker, tallerleaflets, and might not be feasible.

In addition to its irregular, complex shape, which changes size over thecourse of each heartbeat, the mitral valve annulus lacks a significantamount of radial support from surrounding tissue. Compared to aorticvalves, which are completely surrounded by fibro-elastic tissue thatprovides sufficient support for anchoring a prosthetic valve, mitralvalves are bound by muscular tissue on the outer wall only. The innerwall of the mitral valve anatomy is bound by a thin vessel wallseparating the mitral valve annulus from the inferior portion of theaortic outflow tract. As a result, significant radial forces on themitral annulus, such as those imparted by an expanding stent prostheses,could lead to collapse of the inferior portion of the aortic tract.Moreover, larger prostheses exert more force and expand to largerdimensions, which exacerbates this problem for mitral valve replacementapplications.

The chordae tendineae of the left ventricle may also present an obstaclein deploying a mitral valve prosthesis. Unlike aortic valves, mitralvalves have a maze of cordage under the leaflets in the left ventriclethat restrict the movement and position of a deployment catheter and thereplacement device during implantation. As a result, deploying,positioning and anchoring a valve replacement device on the ventricularside of the native mitral valve annulus is complicated.

The present technology provides systems, methods and apparatus to treatheart valves of the body, such as the mitral valve, that address thechallenges associated with the anatomy of the mitral valve. The presenttechnology provides for repositioning and/or removal of a partiallydeployed device, and/or for atraumatic removal of the delivery systemfrom the patient. The apparatus and methods enable a percutaneousapproach using a catheter delivered intravascularly through a vein orartery into the heart, or through a cannula inserted through the heartwall. For example, the apparatus and methods are particularlywell-suited for trans-septal and trans-apical approaches, but can alsobe trans-atrial and direct aortic delivery of a prosthetic replacementvalve to a target location in the heart. Additionally, severalembodiments of the devices and methods as described herein can becombined with many known surgeries and procedures, such as known methodsof accessing the valves of the heart (e.g., the mitral valve ortriscuspid valve) with antegrade or retrograde approaches, andcombinations thereof.

The systems and methods described herein facilitate controlled deliveryof a prosthetic heart valve device using trans-apical or trans-septaldelivery approaches, allow resheathing of the prosthetic heart valvedevice after partial deployment of the device to reposition and/orremove the device, and/or provide for atraumatic removal of the deliverysystems from the patient. Systems in accordance with several embodimentsof the present technology comprise an elongated catheter body, adelivery capsule carried by the catheter body, and an expandableatraumatic member. The delivery capsule includes a platform and ahousing having a sidewall and a proximal rim, and the capsule isconfigured to releasably contain a prosthetic heart valve device. Thehousing is configured to slide along the platform from a containmentconfiguration to a deployment configuration. The expandable atraumaticmember is carried by the capsule (e.g., in the capsule), and theatraumatic member has an opening through which a portion of a supportmember extends, an atraumatic surface, and a peripheral portion. In someembodiments, the atraumatic member has (a) a compacted configuration inwhich the atraumatic member is configured to be located within at leasta portion of an implantable device while constrained with the capsule,and (b) an expanded configuration in which the peripheral portionextends laterally outward beyond the proximal rim of the housing (e.g.,radially outward of the diameter of the proximal rim). In the expandedconfiguration, the implantable device is spaced apart from theatraumatic member, and the atraumatic member is configured to protecttissue of the heart and the vasculature from potentially being damagedby the proximal rim of the housing as the delivery system is withdrawnin a proximal direction through the patient. Additionally, theatraumatic member can expand outwardly against the implantable deviceduring deployment to assist in disengaging the implantable device fromthe capsule.

Access to the Mitral Valve

To better understand the structure and operation of valve replacementdevices in accordance with the present technology, it is helpful tofirst understand approaches for implanting the devices. The mitral valveor other type of atrioventricular valve can be accessed through thepatient's vasculature in a percutaneous manner. By percutaneous it ismeant that a location of the vasculature remote from the heart isaccessed through the skin, typically using a surgical cut down procedureor a minimally invasive procedure, such as using needle access through,for example, the Seldinger technique. The ability to percutaneouslyaccess the remote vasculature is well known and described in the patentand medical literature. Depending on the point of vascular access,access to the mitral valve may be antegrade and may rely on entry intothe left atrium by crossing the inter-atrial septum (e.g., atrans-septal approach). Alternatively, access to the mitral valve can beretrograde where the left ventricle is entered through the aortic valve.Access to the mitral valve may also be achieved using a cannula via atrans-apical approach. Depending on the approach, the interventionaltools and supporting catheter(s) may be advanced to the heartintravascularly and positioned adjacent the target cardiac valve in avariety of manners, as described herein.

FIG. 1 illustrates a stage of a trans-septal approach for implanting avalve replacement device. In a trans-septal approach, access is via theinferior vena cava IVC or superior vena cava SVC, through the rightatrium RA, across the inter-atrial septum IAS, and into the left atriumLA above the mitral valve MV. As shown in FIG. 1, a catheter 1 having aneedle 2 moves from the inferior vena cava IVC into the right atrium RA.Once the catheter 1 reaches the anterior side of the inter-atrial septumIAS, the needle 2 advances so that it penetrates through the septum, forexample at the fossa ovalis FO or the foramen ovale into the left atriumLA. At this point, a guidewire replaces the needle 2 and the catheter 1is withdrawn.

FIG. 2 illustrates a subsequent stage of a trans-septal approach inwhich guidewire 6 and guide catheter 4 pass through the inter-atrialseptum IAS. The guide catheter 4 provides access to the mitral valve forimplanting a valve replacement device in accordance with the technology.

In an alternative antegrade approach (not shown), surgical access may beobtained through an intercostal incision, preferably without removingribs, and a small puncture or incision may be made in the left atrialwall. A guide catheter passes through this puncture or incision directlyinto the left atrium, sealed by a purse string-suture.

The antegrade or trans-septal approach to the mitral valve, as describedabove, can be advantageous in many respects. For example, antegradeapproaches will usually enable more precise and effective centering andstabilization of the guide catheter and/or prosthetic valve device. Theantegrade approach may also reduce the risk of damaging the chordaetendineae or other subvalvular structures with a catheter or otherinterventional tool. Additionally, the antegrade approach may decreaserisks associated with crossing the aortic valve as in retrogradeapproaches. This can be particularly relevant to patients withprosthetic aortic valves, which cannot be crossed at all or withoutsubstantial risk of damage.

FIGS. 3 and 4 show examples of a retrograde approaches to access themitral valve. Access to the mitral valve MV may be achieved from theaortic arch AA, across the aortic valve AV, and into the left ventricleLV below the mitral valve MV. The aortic arch AA may be accessed througha conventional femoral artery access route or through more directapproaches via the brachial artery, axillary artery, radial artery, orcarotid artery. Such access may be achieved with the use of a guidewire6. Once in place, a guide catheter 4 may be tracked over the guidewire6. Alternatively, a surgical approach may be taken through an incisionin the chest, preferably intercostally without removing ribs, andplacing a guide catheter through a puncture in the aorta itself. Theguide catheter 4 affords subsequent access to permit placement of theprosthetic valve device, as described in more detail herein. Retrogradeapproaches advantageously do not need a trans-septal puncture.Cardiologists also more commonly use retrograde approaches, and thusretrograde approaches are more familiar.

FIG. 5 shows a trans-apical approach via a trans-apical puncture. Inthis approach, access to the heart is via a thoracic incision, which canbe a conventional open thoracotomy or sternotomy, or a smallerintercostal or sub-xyphoid incision or puncture. An access cannula isthen placed through a puncture in the wall of the left ventricle at ornear the apex of the heart. The catheters and prosthetic devices of theinvention may then be introduced into the left ventricle through thisaccess cannula. The trans-apical approach provides a shorter,straighter, and more direct path to the mitral or aortic valve. Further,because it does not involve intravascular access, the trans-apicalapproach does not require training in interventional cardiology toperform the catheterizations required in other percutaneous approaches.

Selected Embodiments of Delivery Systems for Prosthetic Heart ValveDevices

FIG. 6 is an isometric view of a hydraulic system 100 (“system 100”) fordelivering a prosthetic heart valve device configured in accordance withat least some embodiments of the present technology. The system 100includes a catheter 102 having an elongated catheter body 108 (“catheterbody 108”) and a delivery capsule 106. The catheter body 108 can includea proximal portion 108 a coupled to a hand held control unit 104(“control unit 104”) and a distal portion 108 b carrying the deliverycapsule 106. The delivery capsule 106 can be configured to contain aprosthetic heart valve device 110 (shown schematically in broken lines).The control unit 104 can provide steering capability (e.g., 360 degreerotation of the delivery capsule 106, 180 degree rotation of thedelivery capsule 106, 3-axis steering, 2-axis steering, etc.) used todeliver the delivery capsule 106 to a target site (e.g., to a nativemitral valve) and deploy the prosthetic heart valve device 110 at thetarget site. The catheter 102 can be configured to travel over aguidewire 120, which can be used to guide the delivery capsule 106 intothe native heart valve. The system 100 can also include a fluid assembly112 configured to supply fluid to and receive fluid from the catheter102 for hydraulically moving the delivery capsule 106 to deploy theprosthetic heart valve device 110.

The fluid assembly 112 includes a fluid source 114 and a fluid line 116fluidically coupling the fluid source 114 to the catheter 102. The fluidsource 114 may contain a flowable substance (e.g., water, saline, etc.)in one or more reservoirs. The fluid line 116 can include one or morehoses, tubes, or other components (e.g., connectors, valves, etc.)through which the flowable substance can pass from the fluid source 114to the catheter 102 and/or through which the flowable substance candrain from the catheter 102 to the fluid source 114. In otherembodiments, the fluid line 116 can deliver the flowable substance tothe catheter 102 from a first reservoir of the fluid source 114 anddrain the flowable substance from the catheter 102 to a separatereservoir. The fluid assembly 112 can also include one or morepressurization devices (e.g., a pump), fluid connectors, fittings,valves, and/or other fluidic components that facilitate moving the fluidto and/or from the fluid source 114. As explained in further detailbelow, the movement of the flowable substance to and from the fluidassembly 112 can be used to deploy the prosthetic heart valve device 110from the delivery capsule 106 and/or resheathe the prosthetic heartvalve device 110 after at least partial deployment.

In certain embodiments, the fluid assembly 112 may comprise a controller118 that controls the movement of fluid to and from the catheter 102.The controller 118 can include, without limitation, one or morecomputers, central processing units, processing devices,microprocessors, digital signal processors (DSPs), and/orapplication-specific integrated circuits (ASICs). To store information,for example, the controller 118 can include one or more storageelements, such as volatile memory, non-volatile memory, read-only memory(ROM), and/or random access memory (RAM). The stored information caninclude, pumping programs, patient information, and/or other executableprograms. The controller 118 can further include a manual input device(e.g., a keyboard, a touch screen, etc.) and/or an automated inputdevice (e.g., a computer, a data storage device, servers, network,etc.). In still other embodiments, the controller 118 may includedifferent features and/or have a different arrangement for controllingthe flow of fluid into and out of the fluid source 114.

The control unit 104 can include a control assembly 122 and a steeringmechanism 124. For example, the control assembly 122 can includerotational elements, such as a knob, that can be rotated to rotate thedelivery capsule 106 about its longitudinal axis 107. The controlassembly 122 can also include features that allow a clinician to controlthe hydraulic deployment mechanisms of the delivery capsule 106 and/orthe fluid assembly 112. For example, the control assembly 122 caninclude buttons, levers, and/or other actuators that initiateunsheathing and/or resheathing the prosthetic heart valve device 110.The steering mechanism 124 can be used to steer the catheter 102 throughthe anatomy by bending the distal portion 108 b of the catheter body 108about a transverse axis. In other embodiments, the control unit 104 mayinclude additional and/or different features that facilitate deliveringthe prosthetic heart valve device 110 to the target site.

The delivery capsule 106 includes a housing 126 configured to carry theprosthetic heart valve device 110 in the containment configuration and,optionally, an end cap 128. The end cap 128 can have an opening 130 atits distal end through which the guidewire 120 can be threaded to allowfor guidewire delivery to the target site. As shown in FIG. 6, the endcap 128 can also have an atraumatic shape (e.g., a partially sphericalshape, a frusto-conical shape, blunt configuration, roundedconfiguration, etc.) to facilitate atraumatic delivery of the deliverycapsule 106 to the target site. In certain embodiments, the end cap 128can also house a portion of the prosthetic heart valve device 110. Thehousing 126 and/or the end cap 128 can be made of metal, polymers,plastic, composites, combinations thereof, or other materials capable ofholding the prosthetic heart valve device 110. The delivery capsule 106is hydraulically driven via the control unit 104 and/or the fluidassembly 112 between a containment configuration for holding theprosthetic heart valve device 110 and a deployment configuration for atleast partially deploying the prosthetic heart valve device 110 at thetarget site. The delivery capsule 106 also allows for resheathing of theprosthetic heart valve device 110 after it has been partially deployed.

FIG. 7A is a cross-sectional view of at least some embodiments of thecapsule 106 in a containment configuration, and FIG. 7B is across-sectional view of the capsule 106 in a deployment configuration.The capsule 106 can be actuated hydraulically and capable of resheathingthe device 110 to either reposition or remove the device 110 from apatient after being partially deployed. In several embodiments, thecapsule 106 includes a support 710 within the housing 126. The support710 can have a central member 711, a platform 712 extending radiallyoutward from a medial portion of the central member 711, and an endplate 714 extending radially outward from an end portion of the centralmember 711. The central member 711 can be an extension of the catheter102 or a separate component attached to the distal end 108 b of thecatheter body 108. The platform 712 and the end plate 714 can beshoulders or flanges having a disk-like shape or other suitable shapes.The support 710 can further include a first orifice 721, a first fluidline 723 coupled to the first orifice 721, a second orifice 722, and asecond fluid line 724 coupled to the second orifice 722.

The housing 126 of the capsule 106 in this embodiment includes a sidewall 730 having a proximal rim 732 and a distal terminus 734. Thesidewall 730 is size to be slightly larger than the outer perimeter ofthe platform 712 and the end plate 714 such that seals 750 (e.g.,O-rings) can fluidically seal against the inner surface of the sidewall730. The housing 126 can further include a flange 740 extending radiallyinwardly from the sidewall 730, and the flange 740 can have an opening742 through which the central member 711 of the support 710 passes. Theflange 740 is configured to carry a seal 752 (e.g., an O-ring) thatseals against the central member 711 of the support 710. The capsule 106of this embodiment is configured to have a first fluid chamber 761between the platform 712 and the flange 740, and a second fluid chamber762 between the flange 740 and the end plate 714. The first fluidchamber 761 is open to the first orifice 721, and a second fluid chamber762 is open to the second orifice 722. The upper portion of the sidewall730 shown in FIG. 7A defines a chamber 770 in the containmentconfiguration in which the prosthetic heart valve device 110 (shownschematically as an annular box) is retained during delivery to a targetsite.

In operation, the housing 126 of the capsule 106 moves between thecontainment and deployment configurations by delivering or draining aflowable substance (e.g., water, saline, etc.) to or from the first andsecond fluid chambers 761 and 762 via the first and second orifices 721and 722, respectively. For example, the housing 126 moves from thecontainment configuration (FIG. 7A) to the deployment configuration(FIG. 7B) by delivering the flowable substance to the first fluidchamber 761 via the first orifice 721 while draining the flowablesubstance from the second fluid chamber 762 via the second orifice 722.Conversely, the housing moves from the deployment configuration (FIG.7B) to the containment configuration (FIG. 7A) by delivering theflowable substance to the second fluid chamber 762 via the secondorifice 722 while draining the flowable substance from the first fluidchamber 761 via the first orifice 721.

The system 100 can further include an expandable atraumatic member 780(“atraumatic member 780”) carried by the capsule 106. As best shown inFIG. 7B, the atraumatic member 780 can include an atraumatic surface 782and a peripheral portion 784. The atraumatic member 780 is configured tobe retained within the capsule 106 in the containment configuration(FIG. 7A) and expand radially outward in the deployment configuration(FIG. 7B) such that at least a peripheral portion of the atraumaticmember 780 extends over at least a portion of the proximal rim 732 ofthe capsule 106 (e.g., radially beyond the diameter of the proximal rim732). Referring to FIG. 7A, at least some embodiments of the atraumaticmember 780 can be compacted and positioned between a distal portion ofthe device 110 and the central member 711 of the support 710 such thatthe atraumatic member 780 can, if necessary, drive the distal portion ofthe device 110 outward to disengage the device 110 from the platform712. In many embodiments, the atraumatic member 780 does not need bepositioned between the device 110 and the central member 711 of thesupport 710, but rather the atraumatic member 780 can be located distalof the distal-most portion of the device 110.

In the deployment configuration shown in FIG. 7B, the proximal rim 732of the housing 126 is positioned distally beyond the distal-mostportions of the device 110 and the atraumatic member 780. The device 110accordingly expands radially outward beyond the housing 126, and theatraumatic member 780 expands such that at least the peripheral portion784 of the atraumatic member 780 is laterally (e.g., radially) outwardwith respect to the proximal rim 732 of the housing 126. For example,the atraumatic member 780 covers the proximal rim 732 in a proximaldirection. The atraumatic member 780 accordingly protects tissue of theheart and vasculature as the catheter 102 is withdrawn proximally toremove the delivery device after deploying the device 110.

Several embodiments of the atraumatic member 780 are shown in FIGS.8A-11. FIG. 8A is an isometric view an expandable atraumatic member 800(“atraumatic member 800”) comprising a truncated conical member having aproximal surface 810, a distal surface 820, an atraumatic surface 822between the proximal surface 810 and the distal surface 820, and aperipheral region 830. At least a portion of the atraumatic surface 822can slope outwardly in the distal direction. The atraumatic surface 822,for example, inclines (e.g., flares) outwardly with increasing distancedistally. As a result, the atraumatic surface 800 directs the capsule106 through openings and the lumens of the vasculature as the catheter102 (FIG. 1) is withdrawn from the patient. The peripheral portion 830of the atraumatic member 800 is configured to cover the proximal rim 732of the housing 126 (FIG. 7B) and thereby prevent the proximal rim 732from damaging the tissue as the catheter 102 is withdrawn. Theatraumatic member 800 further includes an opening 840 configured toreceive the central member 711 of the support 710.

The atraumatic member 800 can be a polymeric material, a braidedmaterial, or a structure formed from individual struts. In the case of apolymeric material, the atraumatic member 800 can be a porous material,such as an open cell foam or closed cell foam. Other polymeric materialsthat expand when unconstrained, such as Silicone, can also be used. Theatraumatic member 800 can alternatively be a cage other structure formedfrom struts or a braid of shape-memory wires or other types of wiresthat have a truncated conical shape in a fully-expanded unbiased state.The wires of the braid can comprises one or more of nitinol, stainlesssteel, drawn filled tubes (e.g., nitinol and platinum), andcobalt-chromium alloy.

FIG. 8B is a side cross-sectional view of some embodiments of theatraumatic member 800 that further include a hub 850 and a disc 860extending distally and radialy outward from the hub 850 in anunconstrained state. The atraumatic member 800 shown in FIG. 8B can bemade from Silicone or some other suitable polymeric material, and thehub 850 and the disc 860 can be formed integrally with each other. Forexample, the hub 850 and the disc 860 can be molded orthree-dimensionally printed from Silicone or another suitable material.The opening 840 can extend through the hub 850. The disc 860 can flexinwardly at the hub 850 to be loaded into a delivery capsule and thenself-expand radially outwardly with respect to the hub whenunconstrained (i.e., released from the delivery capsule). The atraumaticmember 800 shown in FIG. 8B can further include supports 862 (e.g.,arms) on the inner surface of the disc 860. The supports 862 can beformed integrally with the disc 860, such as by molding orthree-dimensional printing, or the supports 862 can be separatecomponents (e.g., metal rods) attached to or molded within the disc 860.

FIGS. 9A and 9B are side views of some embodiments of the atraumaticmember 800 and the housing 126 of the capsule 106 when the housing 126is in different positions. FIG. 9A, more specifically, shows theatraumatic member 800 when the housing 126 is in the fully extendedposition of FIG. 7B after the implantable device and the atraumaticmember 800 have fully expanded. At this stage, the peripheral portion830 of the atraumatic member 800 extends outwardly beyond the radius ofthe proximal rim 732 of the housing 126. FIG. 9B shows the system afterthe housing 126 has been retracted to its original position shown inFIG. 7A causing the atraumatic member 800 to slide proximally along thecentral member 711 (FIG. 9A) of the support. At this stage, theperipheral portion 830 of the atraumatic member 800 remains over theproximal rim 732 of the housing 126 to protect tissue of the heart andvasculature of the patient as the delivery system is withdrawn.

FIG. 10A is a side view illustrating an atraumatic member 900 a inaccordance with several embodiments of the present technology. Theatraumatic member 900 a has hub 910 with a proximal surface 911, anopening 912 to receive the central member 711 of the support 710, and adistal end 913. The hub 910 can be a short tubular member. Theatraumatic member 900 a further includes a plurality of arms 930extending distally from the distal end 913 of the hub 910. FIG. 10Ashows the atraumatic member 900 a in an expanded state in which the arms930 flare radially outwardly in the distal direction. In thisembodiment, the arms 930 have a semi-hyperboloid shape. The arms 930have outer surfaces 932 that together define the atraumatic surface ofthe atraumatic member 900 a.

FIG. 10B is a side view and FIG. 10C is a top view illustrating anatraumatic member 900 b in accordance with several embodiments of thepresent technology. The atraumatic member 900 b is formed from a cuthypo-tube having a plurality of first sections 920 held together by acasing 922 to form a proximal hub 924 (FIG. 10B) and a plurality ofsecond sections 926 that extends distally from the proximal hub 924 todefine a plurality of arms 930 (FIG. 10B). The first sections 926 can bearranged to form an opening 940 (FIG. 10C) configured to receive thecentral member 711 (FIG. 7A) of the support 710 (FIG. 7A). As with theatraumatic member 900 a shown in FIG. 10A, the arms 930 of theatraumatic member 900 b flare radially outwardly in the distal directionwhen the atraumatic member 900 b is in the expanded state. Both of theatraumatic members 900 a and 900 b can be formed from a shape memorymaterial, such as nitinol, or other materials (e.g., stainless steel orpolymeric materials). Additionally, the arms 930 of both of theatraumatic members 900 a and 900 b have outer surfaces 932 that togetherdefine an atraumatic surface.

FIG. 11 is a side view illustrating the atraumatic members 900 a or 900b mounted to the central member 711 in an expanded state in which thearms 930 extend radially outwardly such that the distal peripheralportions of the arms 930 are radially outward of the proximal rim 732 ofthe housing 126. The distal portions of the arms 930 accordingly definea peripheral portion of the atraumatic members 900 a or 900 b thatextend laterally (e.g., radially) outward of the proximal rim 732 tocover the proximal rim 732 of the housing 126 in the proximally facingdirection. In operation, the arms 930 of either of the atraumaticmembers 900 a and 900 b sufficiently cover the proximal rim 732 of thehousing 126 in the proximally facing direction to protect the tissue ofthe heart and/or the vasculature of the patient as the catheter 102 iswithdrawn. Additionally, the radial expansion of the arms 930 can assistin disengaging an implantable device from the capsule by pushingradially outward against a distal portion of the implantable device.

Additional embodiments of the atraumatic members 900 a and 900 b canoptionally include a covering 950 (FIG. 11) over the arms 930. Forexample, a fabric covering made from Dacron®, a braided wire mesh, oranother suitable material can be placed over the outer surface of thearms 930 and/or line the inner surface of the arms 930 to furtherenhance the protective nature of the arms 930. In alternativeembodiments, instead of separate arms 930, the atraumatic members 900 aand 900 b can have a fluted skirt made from a fabric, braided mesh ofmetal wires, or a thin sheet of metal that self-expands radiallyoutwardly when not constricted by the housing 126 of the capsule 106.

In addition to protecting heart and vasculature tissue, atraumaticmembers of the present technology enable the housing 126 to have an openproximal end. Referring to FIG. 7A, for example, the capsule 106 doesnot need a proximal cap that seals to or otherwise covers the proximalrim 732 in the containment configuration. This reduces the length of thecapsule 106, which is desirable to enable the capsule 106 to passthrough turns and corners of the vasculature.

Selected Embodiments of Prosthetic Heart Valve Devices

The delivery systems with atraumatic member described above withreference to FIGS. 6-11 can be configured to deliver various prostheticheart valve devices, such as prosthetic valve devices for replacement ofthe mitral valve and/or other valves (e.g., a bicuspid or tricuspidvalve) in the heart of the patient. Examples of these prosthetic heartvalve devices, system components, and associated methods are describedin this section with reference to FIGS. 12A-25. Specific elements,substructures, advantages, uses, and/or other features of theembodiments described with reference to FIGS. 12A-25 can be suitablyinterchanged, substituted or otherwise configured with one another.Furthermore, suitable elements of the embodiments described withreference to FIGS. 12A-25 can be used as stand-alone and/orself-contained devices.

FIG. 12A is a side cross-sectional view and FIG. 12B is a top plan viewof a prosthetic heart valve device (“device”) 1100 in accordance with anembodiment of the present technology. The device 1100 includes a valvesupport 1110, an anchoring member 1120 attached to the valve support1110, and a prosthetic valve assembly 1150 within the valve support1110. Referring to FIG. 12A, the valve support 1110 has an inflow region1112 and an outflow region 1114. The prosthetic valve assembly 1150 isarranged within the valve support 1110 to allow blood to flow from theinflow region 1112 through the outflow region 1114 (arrows BF), butprevent blood from flowing in a direction from the outflow region 1114through the inflow region 1112.

In the embodiment shown in FIG. 12A, the anchoring member 1120 includesa base 1122 attached to the outflow region 1114 of the valve support1110 and a plurality of arms 1124 projecting laterally outward from thebase 1122. The anchoring member 1120 also includes a fixation structure1130 extending from the arms 1124. The fixation structure 1130 caninclude a first portion 1132 and a second portion 1134. The firstportion 1132 of the fixation structure 1130, for example, can be anupstream region of the fixation structure 1130 that, in a deployedconfiguration as shown in FIG. 12A, is spaced laterally outward apartfrom the inflow region 1112 of the valve support 1110 by a gap G. Thesecond portion 1134 of the fixation structure 1130 can be adownstream-most portion of the fixation structure 1130. The fixationstructure 1130 can be a cylindrical ring (e.g., straight cylinder orconical), and the outer surface of the fixation structure 1130 candefine an annular engagement surface configured to press outwardlyagainst a native annulus of a heart valve (e.g., a mitral valve). Thefixation structure 1130 can further include a plurality of fixationelements 1136 that project radially outward and are inclined toward anupstream direction. The fixation elements 1136, for example, can bebarbs, hooks, or other elements that are inclined only in the upstreamdirection (e.g., a direction extending away from the downstream portionof the device 1100).

Referring still to FIG. 12A, the anchoring member 1120 has a smooth bend1140 between the arms 1124 and the fixation structure 1130. For example,the second portion 1134 of the fixation structure 1130 extends from thearms 1124 at the smooth bend 1140. The arms 1124 and the fixationstructure 1130 can be formed integrally from a continuous strut orsupport element such that the smooth bend 1140 is a bent portion of thecontinuous strut. In other embodiments, the smooth bend 1140 can be aseparate component with respect to either the arms 1124 or the fixationstructure 1130. For example, the smooth bend 1140 can be attached to thearms 1124 and/or the fixation structure 1130 using a weld, adhesive orother technique that forms a smooth connection. The smooth bend 1140 isconfigured such that the device 1100 can be recaptured in a capsule orother container after the device 1100 has been at least partiallydeployed.

The device 1100 can further include a first sealing member 1162 on thevalve support 1110 and a second sealing member 1164 on the anchoringmember 1120. The first and second sealing members 1162, 1164 can be madefrom a flexible material, such as Dacron® or another type of polymericmaterial. The first sealing member 1162 can cover the interior and/orexterior surfaces of the valve support 1110. In the embodimentillustrated in FIG. 12A, the first sealing member 1162 is attached tothe interior surface of the valve support 1110, and the prosthetic valveassembly 1150 is attached to the first sealing member 1162 andcommissure portions of the valve support 1110. The second sealing member1164 is attached to the inner surface of the anchoring member 1120. As aresult, the outer annular engagement surface of the fixation structure1130 is not covered by the second sealing member 1164 so that the outerannular engagement surface of the fixation structure 1130 directlycontacts the tissue of the native annulus.

The device 1100 can further include an extension member 1170. Theextension member 1170 can be an extension of the second sealing member1164, or it can be a separate component attached to the second sealingmember 1164 and/or the first portion 1132 of the fixation structure1130. The extension member 1170 can be a flexible member that, in adeployed state (FIG. 12A), flexes relative to the first portion 1132 ofthe fixation structure 1130. In operation, the extension member 1170provides tactile feedback or a visual indicator (e.g., onechocardiographic or fluoroscopic imaging systems) to guide the device1100 during implantation such that the device 1100 is located at adesired elevation and centered relative to the native annulus. Asdescribed below, the extension member 1170 can include a support member,such as a metal wire or other structure, that can be visualized viafluoroscopy or other imaging techniques during implantation. Forexample, the support member can be a radiopaque wire.

FIGS. 13A and 13B are cross-sectional views illustrating an example ofthe operation of the smooth bend 1140 between the arms 1124 and thefixation structure 1130 in the recapturing of the device 1100 afterpartial deployment. FIG. 13A schematically shows the device 1100 loadedinto a capsule 1700 of a delivery system in a delivery state, and FIG.13B schematically shows the device 1100 in a partially deployed state.Referring to FIG. 13A, the capsule 1700 has a housing 1702, a pedestalor support 1704, and a top 1706. In the delivery state shown in FIG.13A, the device 1100 is in a low-profile configuration suitable fordelivery through a catheter or cannula to a target implant site at anative heart valve.

Referring to FIG. 13B, the housing 1702 of the capsule 1700 has beenmoved distally such that the extension member 1170, fixation structure1130 and a portion of the arms 1124 have been released from the housing1702 in a partially deployed state. This is useful for locating thefixation structure 1130 at the proper elevation relative to the nativevalve annulus A such that the fixation structure 1130 expands radiallyoutward into contact the inner surface of the native annulus A. However,the device 1100 may need to be repositioned and/or removed from thepatient after being partially deployed. To do this, the housing 1702 isretracted (arrow R) back toward the fixation structure 1130. As thehousing 1702 slides along the arms 1124, the smooth bend 1140 betweenthe arms 1124 and the fixation structure 1130 allows the edge 1708 ofthe housing 1702 to slide over the smooth bend 1140 and therebyrecapture the fixation structure 1130 and the extension member 1170within the housing 1702. The device 1100 can then be removed from thepatient or repositioned for redeployment at a better location relativeto the native annulus A. Further aspects of prosthetic heart valvedevices in accordance with the present technology and their interactionwith corresponding delivery devices are described below with referenceto FIGS. 14-25.

FIG. 14 is a top isometric view of an example of the device 1100. Inthis embodiment, the valve support 1110 defines a first frame (e.g., aninner frame) and fixation structure 1130 of the anchoring member 1120defines a second frame (e.g., an outer frame) that each include aplurality of structural elements. The fixation structure 1130, morespecifically, includes structural elements 1137 arranged indiamond-shaped cells 1138 that together form at least a substantiallycylindrical ring when freely and fully expanded as shown in FIG. 14. Thestructural elements 1137 can be struts or other structural featuresformed from metal, polymers, or other suitable materials that canself-expand or be expanded by a balloon or other type of mechanicalexpander.

In several embodiments, the fixation structure 1130 can be a generallycylindrical fixation ring having an outwardly facing engagement surface.For example, in the embodiment shown in FIG. 14, the outer surfaces ofthe structural elements 1137 define an annular engagement surfaceconfigured to press outwardly against the native annulus in the deployedstate. In a fully expanded state without any restrictions, the walls ofthe fixation structure 1130 are at least substantially parallel to thoseof the valve support 1110. However, the fixation structure 1130 can flexinwardly (arrow I) in the deployed state when it presses radiallyoutwardly against the inner surface of the native annulus of a heartvalve.

The embodiment of the device 1100 shown in FIG. 14 includes the firstsealing member 1162 lining the interior surface of the valve support1110, and the second sealing member 1164 along the inner surface of thefixation structure 1130. The extension member 1170 has a flexible web1172 (e.g., a fabric) and a support member 1174 (e.g., metal orpolymeric strands) attached to the flexible web 1172. The flexible web1172 can extend from the second sealing member 1164 without ametal-to-metal connection between the fixation structure 1130 and thesupport member 1174. For example, the extension member 1170 can be acontinuation of the material of the second sealing member 1164. Severalembodiments of the extension member 1170 are thus a malleable or floppystructure that can readily flex with respect to the fixation structure1130. The support member 1174 can have a variety of configurations andbe made from a variety of materials, such as a double-serpentinestructure made from Nitinol.

FIG. 15 is a side view and FIG. 16 is a bottom isometric view of thedevice 1100 shown in FIG. 14. Referring to FIG. 15, the arms 1124 extendradially outward from the base portion 1122 at an angle α selected toposition the fixation structure 1130 radially outward from the valvesupport 1110 (FIG. 14) by a desired distance in a deployed state. Theangle α is also selected to allow the edge 1708 of the delivery systemhousing 1702 (FIG. 13B) to slide from the base portion 1122 toward thefixation structure 1130 during recapture. In many embodiments, the angleα is 15°-75°, or more specifically 15°-60°, or still more specifically30°-45°. The arms 1124 and the structural elements 1137 of the fixationstructure 1130 can be formed from the same struts (i.e., formedintegrally with each other) such that the smooth bend 1140 is acontinuous, smooth transition from the arms 1124 to the structuralelements 1137. This is expected to enable the edge 1708 of the housing1702 to more readily slide over the smooth bend 1140 in a manner thatallows the fixation structure 1130 to be recaptured in the housing 1702of the capsule 1700 (FIG. 13B). Additionally, by integrally forming thearms 1124 and the structural elements 1137 with each other, it inhibitsdamage to the device 1100 at a junction between the arms 1124 and thestructural elements 1137 compared to a configuration in which the arms1124 and structural elements 1137 are separate components and welded orotherwise fastened to each other.

Referring to FIGS. 15 and 16, the arms 1124 are also separated from eachother along their entire length from where they are connected to thebase portion 1122 through the smooth bend 1140 (FIG. 15) to thestructural elements 1137 of the fixation structure 1130. The individualarms 1124 are thus able to readily flex as the edge 1708 of the housing1702 (FIG. 13B) slides along the arms 1124 during recapture. This isexpected to reduce the likelihood that the edge 1708 of the housing 1702will catch on the arms 1124 and prevent the device 1100 from beingrecaptured in the housing 1702.

In one embodiment, the arms 1124 have a first length from the base 1122to the smooth bend 1140, and the structural elements 1137 of thefixation structure 1130 at each side of a cell 1138 (FIG. 14) have asecond length that is less than the first length of the arms 1124. Thefixation structure 1130 is accordingly less flexible than the arms 1124.As a result, the fixation structure 1130 is able to press outwardlyagainst the native annulus with sufficient force to secure the device1100 to the native annulus, while the arms 1124 are sufficientlyflexible to fold inwardly when the device is recaptured in a deliverydevice.

In the embodiment illustrated in FIGS. 14-16, the arms 1124 and thestructural elements 1137 are configured such that each arm 1124 and thetwo structural elements 1137 extending from each arm 1124 formed aY-shaped portion 1142 (FIG. 16) of the anchoring member 1120.Additionally, the right-hand structural element 1137 of each Y-shapedportion 1142 is coupled directly to a left-hand structural element 1137of an immediately adjacent Y-shaped portion 1142. The Y-shaped portions1142 and the smooth bends 1140 are expected to further enhance theability to slide the housing 1702 along the arms 1124 and the fixationstructure 1130 during recapture.

FIG. 17 is a side view and FIG. 18 is a bottom isometric view of aprosthetic heart valve device (“device”) 1200 in accordance with anotherembodiment of the present technology. The device 1200 is shown withoutthe extension member 1170 (FIGS. 14-16), but the device 1200 can furtherinclude the extension member 1170 described above. The device 1200further includes extended connectors 1210 projecting from the base 1122of the anchoring member 1120. Alternatively, the extended connectors1210 can extend from the valve support 1110 (FIGS. 12A-16) in additionto or in lieu of extending from the base 1122 of the anchoring member1120. The extended connectors 1210 can include a first strut 1212 aattached to one portion of the base 1122 and a second strut 1212 battached to another portion of the base 1122. The first and secondstruts 1212 a-b are configured to form a V-shaped structure in whichthey extend toward each other in a downstream direction and areconnected to each other at the bottom of the V-shaped structure. TheV-shaped structure of the first and second struts 1212 a-b causes theextension connector 1210 to elongate when the device 1200 is in alow-profile configuration within the capsule 1700 (FIG. 13A) duringdelivery or partial deployment. When the device 1200 is fully releasedfrom the capsule 1700 (FIG. 13A) the extension connectors 1210foreshorten to avoid interfering with blood flow along the leftventricular outflow tract.

The extended connectors 1210 further include an attachment element 1214configured to releasably engage a delivery device. The attachmentelement 1214 can be a T-bar or other element that prevents the device1200 from being released from the capsule 1700 (FIG. 13A) of a deliverydevice until desired. For example, a T-bar type attachment element 1214can prevent the device 1200 from moving axially during deployment orpartial deployment until the housing 1702 (FIG. 13A) moves beyond theportion of the delivery device engaged with the attachment elements1214. This causes the attachment elements 1214 to disengage from thecapsule 1700 (FIG. 13A) as the outflow region of the valve support 1110and the base 1122 of the anchoring member 1120 fully expand to allow forfull deployment of the device 1200.

FIG. 19 is a side view and FIG. 20 is a bottom isometric view of thedevice 1200 in a partially deployed state in which the device 1200 isstill capable of being recaptured in the housing 1702 of the deliverydevice 1700. Referring to FIG. 19, the device 1200 is partially deployedwith the fixation structure 1130 substantially expanded but theattachment elements 1214 (FIG. 17) still retained within the capsule1700. This is useful for determining the accuracy of the position of thedevice 1200 and allowing blood to flow through the functioningreplacement valve during implantation while retaining the ability torecapture the device 1200 in case it needs to be repositioned or removedfrom the patient. In this state of partial deployment, the elongatedfirst and second struts 1212 a-b of the extended connectors 1210 spacethe base 1122 of the anchoring member 1120 and the outflow region of thevalve support 1110 (FIG. 12A) apart from the edge 1708 of the capsule1700 by a gap G.

Referring to FIG. 20, the gap G enables blood to flow through theprosthetic valve assembly 1150 while the device 1200 is only partiallydeployed. As a result, the device 1200 can be partially deployed todetermine (a) whether the device 1200 is positioned correctly withrespect to the native heart valve anatomy and (b) whether proper bloodflow passes through the prosthetic valve assembly 1150 while the device1200 is still retained by the delivery system 1700. As such, the device1200 can be recaptured if it is not in the desired location and/or ifthe prosthetic valve is not functioning properly. This additionalfunctionality is expected to significantly enhance the ability toproperly position the device 1200 and assess, in vivo, whether thedevice 1200 will operate as intended, while retaining the ability toreposition the device 1200 for redeployment or remove the device 1200from the patient.

FIG. 21 is an isometric view of a valve support 1300 in accordance withan embodiment of the present technology. The valve support 1300 can bean embodiment of the valve support 1110 described above with respect toFIGS. 12A-20. The valve support 1300 has an outflow region 1302, aninflow region 1304, a first row 1310 of first hexagonal cells 1312 atthe outflow region 1302, and a second row 1320 of second hexagonal cells1322 at the inflow region 1304. For purposes of illustration, the valvesupport shown in FIG. 21 is inverted compared to the valve support 1110shown in FIGS. 12A-20 such that the blood flows through the valvesupport 1300 in the direction of arrow BF. In mitral valve applications,the valve support 1300 would be positioned within the anchoring member1120 (FIG. 12A) such that the inflow region 1304 would correspond toorientation of the inflow region 1112 in FIG. 12A and the outflow region1302 would correspond to the orientation of the outflow region 1114 inFIG. 12A.

Each of the first hexagonal cells 1312 includes a pair of firstlongitudinal supports 1314, a downstream apex 1315, and an upstream apex1316. Each of the second hexagonal cells 1322 can include a pair ofsecond longitudinal supports 1324, a downstream apex 1325, and anupstream apex 1326. The first and second rows 1310 and 1312 of the firstand second hexagonal cells 1312 and 1322 are directly adjacent to eachother. In the illustrated embodiment, the first longitudinal supports1314 extend directly from the downstream apexes 1325 of the secondhexagonal cells 1322, and the second longitudinal supports 1324 extenddirectly from the upstream apexes 1316 of the first hexagonal cells1312. As a result, the first hexagonal cells 1312 are offset from thesecond hexagonal cells 1322 around the circumference of the valvesupport 1300 by half of the cell width.

In the embodiment illustrated in FIG. 21, the valve support 1300includes a plurality of first struts 1331 at the outflow region 1302, aplurality of second struts 1332 at the inflow region 1304, and aplurality of third struts 1333 between the first and second struts 1331and 1332. Each of the first struts 1331 extends from a downstream end ofthe first longitudinal supports 1314, and pairs of the first struts 1331are connected together to form first downstream V-struts defining thedownstream apexes 1315 of the first hexagonal cells 1312. In a relatedsense, each of the second struts 1332 extends from an upstream end ofthe second longitudinal supports 1324, and pairs of the second struts1332 are connected together to form second upstream V-struts definingthe upstream apexes 1326 of the second hexagonal cells 1322. Each of thethird struts 1333 has a downstream end connected to an upstream end ofthe first longitudinal supports 1314, and each of the third struts 1333has an upstream end connected to a downstream end of one of the secondlongitudinal supports 1324. The downstream ends of the third struts 1333accordingly define a second downstream V-strut arrangement that formsthe downstream apexes 1325 of the second hexagonal cells 1322, and theupstream ends of the third struts 1333 define a first upstream V-strutarrangement that forms the upstream apexes 1316 of the first hexagonalcells 1312. The third struts 1333, therefore, define both the firstupstream V-struts of the first hexagonal cells 1312 and the seconddownstream V-struts of the second hexagonal cells 1322.

The first longitudinal supports 1314 can include a plurality of holes1336 through which sutures can pass to attach a prosthetic valveassembly and/or a sealing member. In the embodiment illustrated in FIG.21, only the first longitudinal supports 1314 have holes 1336. However,in other embodiments the second longitudinal supports 1324 can alsoinclude holes either in addition to or in lieu of the holes 1336 in thefirst longitudinal supports 1314.

FIG. 22 is a side view and FIG. 23 is a bottom isometric view of thevalve support 1300 with a first sealing member 1162 attached to thevalve support 1300 and a prosthetic valve 1150 within the valve support1300. The first sealing member 1162 can be attached to the valve support1300 by a plurality of sutures 1360 coupled to the first longitudinalsupports 1314 and the second longitudinal supports 1324. At least someof the sutures 1360 coupled to the first longitudinal supports 1314 passthrough the holes 1336 to further secure the first sealing member 1162to the valve support 1300.

Referring to FIG. 23, the prosthetic valve 1150 can be attached to thefirst sealing member 1162 and/or the first longitudinal supports 1314 ofthe valve support 1300. For example, the commissure portions of theprosthetic valve 1150 can be aligned with the first longitudinalsupports 1314, and the sutures 1360 can pass through both the commissureportions of the prosthetic valve 1150 and the first sealing member 1162where the commissure portions of the prosthetic valve 1150 are alignedwith a first longitudinal support 1314. The inflow portion of theprosthetic valve 1150 can be sewn to the first sealing member 1162.

The valve support 1300 illustrated in FIGS. 21-23 is expected to be wellsuited for use with the device 1200 described above with reference toFIGS. 17-20. More specifically, the first struts 1331 cooperate with theextended connectors 1210 (FIGS. 17-20) of the device 1200 to separatethe outflow portion of the prosthetic valve 1150 from the capsule 1700(FIGS. 19-20) when the device 1200 is in a partially deployed state. Thefirst struts 1331, for example, elongate when the valve support 1300 isnot fully expanded (e.g., at least partially contained within thecapsule 1700) and foreshorten when the valve support is fully expanded.This allows the outflow portion of the prosthetic valve 1150 to bespaced further apart from the capsule 1700 in a partially deployed stateso that the prosthetic valve 1150 can at least partially function whenthe device 1200 (FIGS. 17-20) is in the partially deployed state.Therefore, the valve support 1300 is expected to enhance the ability toassess whether the prosthetic valve 1150 is fully operational in apartially deployed state.

FIGS. 24 and 25 are schematic side views of valve supports 1400 and1500, respectively, in accordance with other embodiments of the presenttechnology. Referring to FIG. 24, the valve support 1400 includes afirst row 1410 of first of hexagonal cells 1412 and a second row 1420 ofsecond hexagonal cells 1422. The valve 1400 can further include a firstrow 1430 of diamond-shaped cells extending from the first hexagonalcells 1412 and a second row 1440 of diamond-shaped cells extending fromthe second hexagonal cells 1422. The additional diamond-shaped cellselongate in the low-profile state, and thus they can further space theprosthetic valve 1150 (shown schematically) apart from a capsule of adelivery device. Referring to FIG. 25, the valve support 1500 includes afirst row 1510 of first hexagonal cells 1512 at an outflow region 1502and a second row 1520 of second hexagonal cells 1522 at an inflow region1504. The valve support 1500 is shaped such that an intermediate region1506 (between the inflow and outflow regions 1502 and 1504) has asmaller cross-sectional area than that of the outflow region 1502 and/orthe inflow region 1504. As such, the first row 1510 of first hexagonalcells 1512 flares outwardly in the downstream direction and the secondrow 1520 of second hexagonal cells 1522 flares outwardly in the upstreamdirection.

Examples

Several aspects of the present technology are set forth in the followingexamples.

1. A system for delivering a prosthetic heart valve device into a heartof a patient, the system comprising:

-   -   an elongated catheter body;    -   a delivery capsule carried by the elongated catheter body, the        delivery capsule including a platform and a housing having a        sidewall and a proximal rim, the housing being configured to        slide along the platform from a containment configuration to a        deployment configuration, and the platform and the sidewall        defining a chamber for retaining a prosthetic heart valve device        in the containment configuration; and    -   an expandable atraumatic member associated with the capsule, the        atraumatic member having an opening, an atraumatic surface, and        a peripheral portion, wherein the atraumatic member is        configured to be in (a) a compacted configuration in which the        atraumatic member is within the chamber in the containment        configuration and (b) an expanded configuration in which the        peripheral portion extends laterally outward over the proximal        rim of the housing in the deployment configuration.

2. The system of example 1 wherein the housing is open at the proximalrim such that the chamber is open facing proximally in the containmentconfiguration.

3. The system of any of the foregoing examples wherein the atraumaticmember comprises a truncated conical member.

4. The system of any of the foregoing examples wherein the truncatedconical member comprises foam, an elastomer, or a braided wire.

5. The system of any of the foregoing examples wherein the atraumaticmember comprises a hub and arms that flare outwardly in the expandedconfiguration.

6. The system of example 5 wherein the arms comprise a shape memorymaterial.

7. The system of any of the foregoing examples wherein the atraumaticmember comprises arms having distal portions that flare radially outwardin a distal direction in the expanded configuration.

8. The system of any of the foregoing examples wherein the atraumaticsurface is an inclined surface that flares outwardly in a distaldirection.

9. The system of example 8 wherein the inclined surface is defined by anoutwardly flared arm.

10. The system of any of the foregoing examples, further comprising aprosthetic heart valve device in a low-profile state in the chamber inthe containment configuration, and wherein the atraumatic member iswithin a distal portion of the prosthetic heart valve device in thecompacted configuration.

11. A system for treating a native heart valve, comprising:

-   -   an elongated catheter body;    -   a delivery capsule carried by the elongated catheter body, the        delivery capsule including a support and a housing, the support        having a platform, the housing having a sidewall and a proximal        rim, and the housing being configured to slide along the        platform from a containment configuration to a deployment        configuration, and wherein the housing and the platform define a        chamber in the containment configuration;    -   an expandable prosthetic heart valve device at least partially        within the chamber of the housing in the containment        configuration; and    -   an expandable atraumatic member carried by the capsule, the        atraumatic member having an opening through which the support        extends, a proximal atraumatic surface, and a peripheral        portion, wherein the atraumatic member is configured to (a) have        a first diameter in a compacted configuration and (b) expand        outwardly to a second diameter greater than the first diameter        in an expanded configuration when the prosthetic heart valve        device is released from the chamber such that the peripheral        portion extends laterally outward of the proximal rim of the        housing.

12. The system of example 11 wherein, when the atraumatic member is inthe compacted configuration, the atraumatic member is between thesupport of the capsule and the prosthetic heart valve device.

13. The system of any of examples 11-12 wherein the atraumatic membercomprises a truncated conical member.

14. The system of example 13 wherein the truncated conical membercomprises foam, an elastomer, or a braided wire.

15. The system of any of examples 11-14 wherein the atraumatic membercomprises a hub and arms that flare outwardly in the expandedconfiguration.

16. The system of example 15 wherein the arms comprise a shape memorymaterial.

17. The system of any of examples 11-16 wherein the atraumatic membercomprises a hub and an expandable member attached to the hub, andwherein the expandable member flares radially outward in a distaldirection in the expanded configuration.

18. The system of any of examples 11-17 wherein the atraumatic surfaceis an inclined surface that flares outwardly in a distal direction.

19. The system of example 18 wherein the inclined surface is a foamsurface.

20. The system of example 18 wherein the inclined surface is defined byan outwardly flared arm.

21. A method of delivering a prosthetic heart valve device, comprising:

-   -   positioning a delivery capsule carrying a prosthetic heart valve        at a native heart valve within a heart of a human, wherein the        capsule is in a containment configuration;    -   moving a housing of the capsule from the containment        configuration to a deployed configuration whereby the prosthetic        heart valve self-expands and releases from the capsule; and    -   causing an atraumatic member to expand from a compacted        configuration in which the atraumatic member has a first        diameter to an expanded configuration in which the atraumatic        member has a second diameter greater than the first diameter        such that a peripheral portion of the atraumatic member extends        laterally outward relative to a proximal rim of the housing.

CONCLUSION

The above detailed descriptions of embodiments of the technology are notintended to be exhaustive or to limit the technology to the precise formdisclosed above. Although specific embodiments of, and examples for, thetechnology are described above for illustrative purposes, variousequivalent modifications are possible within the scope of the technologyas those skilled in the relevant art will recognize. For example,although steps are presented in a given order, alternative embodimentsmay perform steps in a different order. Additionally, various featuresof several embodiments of the atraumatic members shown and describedwith reference to FIGS. 7A-11 can be interchanged with each other. Forexample, all of the atraumatic member can optionally include a fabric orwire-braided covering. The various embodiments described herein may alsobe combined to provide further embodiments.

From the foregoing, it will be appreciated that specific embodiments ofthe technology have been described herein for purposes of illustration,but well-known structures and functions have not been shown or describedin detail to avoid unnecessarily obscuring the description of theembodiments of the technology. Where the context permits, singular orplural terms may also include the plural or singular term, respectively.

Moreover, unless the word “or” is expressly limited to mean only asingle item exclusive from the other items in reference to a list of twoor more items, then the use of “or” in such a list is to be interpretedas including (a) any single item in the list, (b) all of the items inthe list, or (c) any combination of the items in the list. Additionally,the term “comprising” is used throughout to mean including at least therecited feature(s) such that any greater number of the same featureand/or additional types of other features are not precluded. It willalso be appreciated that specific embodiments have been described hereinfor purposes of illustration, but that various modifications may be madewithout deviating from the technology. Further, while advantagesassociated with certain embodiments of the technology have beendescribed in the context of those embodiments, other embodiments mayalso exhibit such advantages, and not all embodiments need necessarilyexhibit such advantages to fall within the scope of the technology.Accordingly, the disclosure and associated technology can encompassother embodiments not expressly shown or described herein.

We claim:
 1. A system for delivering a prosthetic heart valve deviceinto a heart of a patient, the system comprising: an elongated catheterbody including a distal portion and proximal portion; a delivery capsulecarried by the elongated catheter body on the distal portion, thedelivery capsule including a platform and a housing having a sidewalland a proximal rim, the housing being configured to slide along theplatform from a containment configuration to a deployment configuration,and the platform and the sidewall defining a chamber for retaining aprosthetic heart valve device in the containment configuration; and anexpandable atraumatic member associated with the delivery capsule, theatraumatic member having an opening, an atraumatic surface, and aperipheral portion, wherein the atraumatic member is configured to be in(a) a compacted configuration in which the atraumatic member is withinthe chamber in the containment configuration and (b) an expandedconfiguration in which the peripheral portion extends laterally outwardover the proximal rim of the housing in the deployment configuration,wherein, when the expandable atraumatic member is in the expandedconfiguration: the atraumatic surface and the peripheral portion of theexpandable atraumatic member are located proximal to the proximal rim ofthe delivery capsule with the atraumatic surface being proximal to theperipheral portion, the peripheral portion of the expandable atraumaticmember covers the proximal rim around an outer perimeter of the deliverycapsule in the deployment configuration when the delivery capsule iswithdrawn in a proximal direction from tissue of the patient, and theexpandable atraumatic member is tapered in a distal direction.
 2. Thesystem of claim 1, wherein the housing is open at the proximal rim suchthat the chamber is open facing proximally in the containmentconfiguration.
 3. The system of claim 1, wherein the atraumatic membercomprises a truncated conical member including the atraumatic surfacesloping outwardly in the distal direction between a proximal surface anda distal surface of the truncated conical member.
 4. The system of claim3, wherein the truncated conical member comprises foam, an elastomer, ora braided wire.
 5. The system of claim 1, wherein the atraumatic membercomprises a hub and arms that flare outwardly in the expandedconfiguration.
 6. The system of claim 5, wherein the arms comprise ashape memory material.
 7. The system of claim 1, wherein the atraumaticmember comprises arms having distal portions that flare radially outwardin the distal direction in the expanded configuration.
 8. The system ofclaim 1, wherein the atraumatic surface is an inclined surface thatflares outwardly in the distal direction.
 9. The system of claim 8,wherein the inclined surface is defined by an outwardly flared arm. 10.The system of claim 1, further comprising a prosthetic heart valvedevice in a low-profile state in the chamber in the containmentconfiguration, and wherein the atraumatic member is within a distalportion of the prosthetic heart valve device in the compactedconfiguration.
 11. The system of claim 1, wherein, when the expandableatraumatic member is in the expanded configuration, the at least aportion of the atraumatic surface slopes outwardly in the distaldirection to direct the delivery capsule through at least one of anopening or a lumen of a vasculature of a patient when the deliverycapsule is withdrawn in a proximal direction from the patient.
 12. Thesystem of claim 1, wherein the peripheral portion that is configured tocover the proximal rim of the delivery capsule when the expandableatraumatic member is in the expanded configuration is a distal-mostportion of the expandable atraumatic member.
 13. The system of claim 1,wherein the peripheral portion is configured to be adjacent to theproximal rim of the delivery capsule when the expandable atraumaticmember is in the expanded configuration.
 14. The system of claim 1,wherein, when the expandable atraumatic member is in the expandedconfiguration, the expandable atraumatic member is tapered in the distaldirection such that a proximal end of the expandable atraumatic memberdoes not extend laterally outwards over the proximal rim of the housing.15. A system for treating a native heart valve, comprising: an elongatedcatheter body including a distal portion and proximal portion; adelivery capsule carried by the elongated catheter body on the distalportion, the delivery capsule including a support and a housing, thesupport having a platform, the housing having a sidewall and a proximalrim, and the housing being configured to slide along the platform from acontainment configuration to a deployment configuration, and wherein thehousing and the platform define a chamber in the containmentconfiguration; an expandable prosthetic heart valve device at leastpartially within the chamber of the housing in the containmentconfiguration; and an expandable atraumatic member carried by thedelivery capsule, the atraumatic member having an opening through whichthe support extends, a proximal atraumatic surface, and a peripheralportion, wherein the atraumatic member is configured to (a) have a firstdiameter in a compacted configuration and (b) expand outwardly to asecond diameter greater than the first diameter in an expandedconfiguration when the prosthetic heart valve device is released fromthe chamber such that the peripheral portion extends laterally outwardof the proximal rim of the housing wherein, when the expandableatraumatic member is in the expanded configuration: the proximalatraumatic surface and the peripheral portion of the expandableatraumatic member are located proximal to the proximal rim of thedelivery capsule with the proximal atraumatic surface being proximal tothe peripheral portion, the peripheral portion of the expandableatraumatic member covers the proximal rim around an outer perimeter ofthe delivery capsule in the deployment configuration when the deliverycapsule is withdrawn in a proximal direction from tissue of the patient,and the expandable atraumatic member is tapered in a distal direction.16. The system of claim 15, wherein, when the atraumatic member is inthe compacted configuration, the atraumatic member is between thesupport of the capsule and the prosthetic heart valve device.
 17. Thesystem of claim 15, wherein the atraumatic member comprises a truncatedconical member including the atraumatic surface sloping outwardly in thedistal direction between a proximal surface and a distal surface of thetruncated conical member.
 18. The system of claim 17, wherein thetruncated conical member comprises foam, an elastomer, or a braidedwire.
 19. The system of claim 15, wherein the atraumatic membercomprises a hub and arms that flare outwardly in the expandedconfiguration.
 20. The system of claim 15, wherein the arms comprise ashape memory material.
 21. The system of claim 15, wherein theatraumatic member comprises a hub and an expandable member attached tothe hub, and wherein the expandable member flares radially outward inthe distal direction in the expanded configuration.
 22. The system ofclaim 15, wherein the atraumatic surface is an inclined surface thatflares outwardly in the distal direction.
 23. The system of claim 22,wherein the inclined surface is a foam surface.
 24. The system of claim22, wherein the inclined surface is defined by an outwardly flared arm.25. A method of delivering a prosthetic heart valve device, the methodcomprising: positioning a delivery capsule carrying a prosthetic heartvalve at a native heart valve within a heart of a human while thedelivery capsule is in a containment configuration, wherein the deliverycapsule is carried on a distal portion of an elongated catheter body,the delivery capsule including a platform and a housing having asidewall and a proximal rim, the housing being configured to slide alongthe platform from the containment configuration to a deploymentconfiguration, and the platform and the sidewall defining a chamber forretaining the prosthetic heart valve device in the containmentconfiguration; moving the housing of the capsule from the containmentconfiguration to the deployed configuration whereby the prosthetic heartvalve self-expands and releases from the capsule; causing an expandableatraumatic member associated with the delivery capsule to expand from acompacted configuration in which the expandable atraumatic member has afirst diameter to an expanded configuration in which the atraumaticmember has a second diameter greater than the first diameter such that aperipheral portion of the atraumatic member extends laterally outwardrelative to a proximal rim of the housing; and withdrawing the deliverycapsule in a proximal direction with the expandable atraumatic member inthe expanded configuration, wherein the atraumatic member has anopening, an atraumatic surface, and a peripheral portion, wherein theatraumatic member is configured to be in (a) the compacted configurationin which the atraumatic member is within the chamber in the containmentconfiguration and (b) the expanded configuration in which the peripheralportion extends laterally outward over the proximal rim of the housingin the deployment configuration, wherein, when the expandable atraumaticmember is in the expanded configuration: the atraumatic surface and theperipheral portion of the expandable atraumatic member are locatedproximal to the proximal rim of the delivery capsule with the atraumaticsurface being proximal to the peripheral portion, the peripheral portionof the expandable atraumatic member covers the proximal rim around anouter perimeter of the delivery capsule in the deployment configurationwhen the delivery capsule is withdrawn in a proximal direction fromtissue of the patient, and the expandable atraumatic member is taperedin a distal direction.